510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942593Substantially Equivalent

Oxychek Oxygen Analyzer

Nidek Medical Products Inc, Birmingham AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942593 is the FDA 510(k) clearance record for OXYCHEK OXYGEN ANALYZER, a class II device, cleared for Nidek Medical Products, Inc. on under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). FDA records list 12 510(k) clearances for Nidek Medical Products, Inc., from to . As of , FDA records show no recalls naming K942593.

Clearance record

Decision date
Received
(336 days to decision)
Product code
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Regulation
21 CFR 868.1720
Device class
Class II
Review panel
Anesthesiology
Applicant
Nidek Medical Products, Inc. 3949 Valley E. Industrial Dr., Birmingham AL
510(k) summary
Statement
Third party review
No

Clearances, product code CCL

Trailing 12 months
1 clearance under product code CCL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CCL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260